Wacker Biotech said today that it won FDA approval to start producing reteplase, the active ingredient in Chiesi‘s thrombolysis drug, Retavase. The medication, which is designed to treat acute myocardial infarction in adults, will be marketed in the U.S. by Chiesi and made in Wacker’s Germany-based plant. Wacker reported that it landed approval to commercially […]
Catalent dishes out $950m for biologics manufacturer
Catalent said today that it plans to purchase Cook Pharmica for $950 million in cash. Cook Pharmica, a unit of privately-held medical device maker Cook Group, is a contract manufacturer that develops biologics-based drug compounds. The deal readies Catalent for an expansion of its biologics biz. Catalent will have access to Cook Pharmica’s Indiana-based facility […]
LabCorp completes $1.2B Chiltern buy
Diagnostics company LabCorp (NYSE:LH) said today that it has closed its $1.2 billion acquisition of contract research organization Chiltern International. Chiltern is slated to fold into the company’s Covance drug development business, which conducts clinical trials for drugmakers. “The addition of Chiltern advances a key element of LabCorp’s strategy – to bring innovative medicines to patients […]
Contract manufacturer Althea launches sterile vial filling line
Contract development & manufacturing organization Althea, an Ajinomoto company, announced today the launch of a new, high-performance sterile vial filling line. The Optima VFVM 7000 aseptic fill finish line adds to Althea’s drug product manufacturing capabilities and enables the company to work with larger batch sizes and a broader range of filling volumes – up […]
Manufacturing drug device products: challenges and best practices
Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable. There’s a lot to consider when manufacturing a medical […]
Aerie’s contract manufacturer faces regulatory hurdle
Aerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates. The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA […]
Icon beats Street on Q2 earnings, acquires Mapi Group
Drug development provider Icon PLC (Nasdaq: ICLR) saw its stock jump about 6% in value today after announcing second-quarter earnings that beat analysts’ expectations. The Dublin, Ireland–based company, which serves the pharmaceutical, biotechnology and medical device industries, also said it has acquired the Mapi Group, which provides patient-centered health outcomes research and commercialisation. Financial terms of […]
MW Industries launches MW Industries Medical Solutions
MW Industries – a maker of springs, specialty fasteners, machined parts and other precision components – today announced the launch of a medtech-focused MW Industries Medical Solutions. MW Industries (Rosemont, Ill.) will be touting its capabilities this week in New York at MD&M East (Booth 721). MW Industries Medical Solutions’s business involves precision metal components […]
11 companies with interesting technology at MD&M East
Thousands of engineers and executives are expected to descend on the Javits Center in New York next week for MD&M East, the largest medical device manufacturing event on the East Coast. Fun attractions include Apple co-founder Steve “Woz” Wozniak delivering a keynote speech, the 19th annual Medical Design Excellence Awards, robot battles and a 3D printed […]
Chiltern acquires Integrated Development Associates
Contract research organization Chiltern announced today that it is expanding its Japanese and Asian presence through its purchase of Integrated Development Associates. Financial terms of the deal were not disclosed. IDA has staff in Japan, Korea and Southeast Asia – and offers opportunities to integrate the region into global drug development, according to Chiltern. IDA’s expertise includes […]
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